EMA Frequently asked Questions about Parallel Distribution (Rev. 6, Oct 2025)
The European Medicines Agency (EMA) has released an updated FAQ document (Rev. 6, Oct 2025) detailing procedures and obligations for parallel distribution of centrally authorised medicinal products (CAPs) within the EU.
The guidance confirms that parallel distribution notifications are mandatory and outlines key processes including initial notification, bulk changes, status updates, and annual updates.
Notable clarifications include stricter requirements for repackaging, mandatory inclusion of QR codes if listed in product annexes, and updated rules for dormant notices.
Parallel distributors must ensure compliance with the latest marketing authorisation, report quality defects, and maintain proper labelling, including braille and blue box elements.
The document also introduces new formatting standards, submission protocols via the IRIS platform, and updates to the fee structure effective January 2025.
The following questions were updated:
- 1.5. What if a Notice for PD cannot be issued? Rev. Oct 2025
- 1.9. What are the post-PD notice obligations of a parallel distributor? Rev. Oct 2025
- 1.15. How does the Protocol on Ireland / Northern Ireland affect parallel distribution? Rev. Oct 2025
- 3.14. What are the requirements for QR codes on the packaging material? NEW Oct 2025
- 3.20. Who receives Notices for PD? Rev. Oct. 2025